Pediococcus Acidilactici PA53 Supplementation Improves Stool Form and Modulates Gut Microbiota and Inflammatory Responses in Adults With Functional Constipation: A Randomized, Double-Blind, Placebo-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 2
- 主要终点
- Constipation symptom improvement
研究概览
简要总结
To study the improvement of constipation symptoms, quality of life and mental state, intestinal function, intestinal hormones, inflammation and immunity, and intestinal flora of constipation subjects after 8-week intervention with Pediococcus acidilactici PA53.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(1) age 18-70 years; (2) fewer than three SBMs per week and/or BSFS type 1 or 2; (3) ability to comply with study requirements; (4) provision of signed informed consent; (5) for participants of childbearing potential (including both sexes), agreement to use effective contraception from 14 days before screening until 6 months after study completion.
排除标准
- •(1) consumption of food or drugs known to affect gastrointestinal function (e.g., laxatives, probiotics) within 4 weeks prior to enrollment; (2) a change in dietary habits within the past month or planned during the study; (3) pregnancy, lactation, or intention to become pregnant; (4) history of severe cardiovascular, pulmonary, hepatic, renal, metabolic (e.g., diabetes, thyroid disease), malignant, or immunological disorders; (5) antibiotic use within 4 weeks prior to the study; (6) severe psychiatric illness; (7) any other condition deemed by the investigators to make the participant unsuitable for the trial.
研究组 & 干预措施
Placebo
Every day to give 3 g maltodextrin intervention for 8 weeks. Store in a cool and dry place.
干预措施: Maltodextrin (Dietary Supplement)
Probiotic
Every day to Pediococcus acidilactici PA53 (30 billion CFU/day, 3g) intervention, for 8 weeks.
Store in a cool and dry place.
干预措施: Probiotic (Dietary Supplement)
结局指标
主要结局
Constipation symptom improvement
时间窗: 8 weeks
Assessing the improvement of constipation in patients using the Bristol Stool Form Scale (BSFS) . In this scale, higher scores indicate softer stool textures, closer to liquid consistency. Scores of 4, 5, and 6 are generally considered ideal stool characteristics.
次要结局
未报告次要终点